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Spine Wave, Inc.

Last updated September 17, 2026

Information

Country: US
Address: THREE ENTERPRISE DR., SHELTON, CT, 06484
Website: spinewave.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 203-944-9494
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3004638600
DUNS Number: 067789763

Catalogue (3604)

Page 5 of 73

Device	Model / Reference	Registries	Class	Status
Proficient® Posterior Cervical Spine System	21-8634	FDA UDI	Class II	Active
True Position® Spacer System	1208-01-2713	FDA UDI	Class II	Active
Salvo® Spine System	10-6306	FDA UDI	Class I	Active
Salvo® Spine System	13-8192	FDA UDI	Class I	Active
Proficient™ Posterior Cervical Spine System	21-8346	FDA UDI	Class II	Active
Salvo® Spine System	13-8162	FDA UDI	Class I	Active
Sniper® Spine System	11-4369	FDA UDI	Class II	Active
Leva® Anterior Interbody System	11-0088	FDA UDI	Class II	Active
Sniper® Spine System	11-4851	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	21-8538	FDA UDI	Class II	Active
Salvo® Spine System	11-6948	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8338	FDA UDI	Class II	Active
Abacus® Spacer System	11-9058	FDA UDI	Class II	Active
Abacus® Spacer System	11-9028	FDA UDI	Class II	Active
Stronghold® 3D Titanium Interbody Device System	SW19109-3008	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	21-8588	FDA UDI	Class II	Active
Sniper® Spine System	11-4845	FDA UDI	Class II	Active
Defender™ Anterior Cervical Plate System	15-5478	FDA UDI	Class II	Active
Salvo® Spine System	21-0059	FDA UDI	Class II	Active
Spine Wave Instruments	10-1105	FDA UDI	Class I	Active
True Position® Spacer System	1208-01-3611	FDA UDI	Class II	Active
StaXx® IBL System	11-1445	FDA UDI	Class II	Active
Leva® Anterior Interbody System	11-0216	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8925	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	21-8405	FDA UDI	Class II	Active
CapSure® Spine System	11-3360	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	21-8326	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8025	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	10-8564	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	21-8662	FDA UDI	Class II	Active
Salvo® Spine System	10-8285	FDA UDI	Class I	Active
Salvo® Spine System	11-6858	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8409	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	21-8549	FDA UDI	Class II	Active
Leva® Anterior Interbody System	11-0063	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	21-8618	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-9746	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8987	FDA UDI	Class II	Active
Salvo® Spine System	11-7493	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-9708	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	21-8513	FDA UDI	Class II	Active
Proficient™ Posterior Cervical Spine System	11-8085	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	11-9778	FDA UDI	Class II	Active
Salvo® Spine System	11-6683	FDA UDI	Class II	Active
Sniper® Spine System	11-4080	FDA UDI	Class II	Active
Proficient® Posterior Cervical Spine System	21-9151	FDA UDI	Class II	Active
Abacus® Spacer System	11-9033	FDA UDI	Class II	Active
Sniper® Spine System	11-4455	FDA UDI	Class II	Active
CapSure® Spine System	11-3351	FDA UDI	Class II	Active
Sniper® Spine System	11-4545	FDA UDI	Class II	Active

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FDA Recalls (2)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
May 4, 2015	Z-1960-2015	—	terminated	Mislabeled outer carton: Monopolar Probe is listed as 200 x 1.5mm when it should be listed as 280 x 1.5mm
May 14, 2013	Z-2187-2013	—	terminated	A component Superior endplate manufactured from a different polymer than specified